Transplants of various organs, such as the liver, kidney, lung and heart, are regularly performed as treatment for endstage organ disease. Allograft as well as xenograft transplants have been performed. Organ transplantation is often the best replacement therapy for patients suffering from organ disease, and offers patients an improved quality of life. Although many of these grafts survive in the short term, the long term maintenance of the grafts is often poor. Two primary causes of graft failure are cell-mediated rejection (CMR) and antibody-mediated rejection.
Antibody mediated rejection (AMR) occurs in 10-15% of the renal transplant population and, unlike other forms of rejection, is frequently irreversible. Antibodies, which mediate AMR, are difficult to fully remove therapeutically and often lead to allograft sensitization of the patient. The dire cost of sensitization is an often necessary second transplant, which is prone to even higher rejection rates. Re-transplantation further reduces the donor pool, thereby, placing an undue burden on an already stressed system.
The diagnosis for AMR currently consists of a combination of invasive and expensive assays that include detection of donor specific antibody in the patients' serum as well as histological evidence obtained by biopsy. For instance, current methods for testing for AMR following renal transplant are tedious and involve detection of CD4 staining in peritubular capillaries, together with a positive post-transplantation cross-match and evidence of histologic damage. To date, there is no inexpensive, single, straightforward test that demonstrates AMR conclusively.
Therefore, it would be useful to identify methods, compositions and kits that can non-invasively and accurately determine if an individual is or will undergo AMR.